Roche takes Polivy’s coveted victory in newly diagnosed lymphoma. But is it enough to change 2 decades of established therapeutic practices?

After two years of meager sales for Polivy, Roche is announcing a coveted clinical victory that could open a successful market for the drug. Yet questions remain as to the exact size of the opportunity.

In previously untreated diffuse large B-cell lymphoma (DLBCL) patients, a Polivy regimen prolonged the time to cancer progression or death compared to the standard treatment known as R-CHOP, unveiled on Monday Genentech from Roche.

Phase 3 POLARIX trial’s progression-free survival victory marks the first time in 20 years that a drug has significantly improved over standard therapy in newly diagnosed DLBCL, Roche Chief Medical Officer noted , Levi Garraway, MD, Ph.D ..

The victory could open up a great market opportunity. Recently, Roche’s chief pharmaceutical officer Bill Anderson estimated that the front-line DLBCL field could be worth $ 2 billion for Polivy. In a recent note to investors, analysts at Jefferies estimated that the indication could open up a $ 3 billion market for Polivy “if the results of the Polarix study are convincing.”

It’s a big if.

R-CHOP, the current standard of care in first-line DLBCL, includes Roche Rituxan, the chemotherapies cyclophosphamide, doxorubicin and vincristine, and the corticosteroid prednisone. For the Polivy diet, Roche replaced vincristine (O) with Polivy, a CD79b-targeted antibody-drug body conjugate.

As industry watchers are well aware, the R-CHOP diet has set a very high efficiency bar that has not been exceeded for almost two decades.

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Now that Polivy has claimed a “dramatically improved and clinically significant” victory in progression-free survival, the question remains what the exact magnitude of the improvement is and whether it is transformative enough to change the treatment paradigm. .

Additionally, writing to clients a month ago, analysts at Jefferies said they wanted to see if the Polivy diet had any safety benefits related to peripheral neuropathy. Roche did not add Polivy to R-CHOP for the trial due to concerns about the potential safety issues of neuropathy aggravated with vincristine. The team also highlighted the low platelet count as a potential problem for Polivy and R-CHOP based on previous data.

Roche will present the detailed results of POLARIX at an upcoming medical meeting and submit them to health authorities, the company said.

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Polivy is currently licensed in third-line DLBCL, competing in part against CAR-T therapies from Novartis, Kite Pharma from Gilead Sciences and Bristol Myers Squibb, as well as a newly approved ADC rival from ADC Therapeutics. Thanks to this limited and late use, Polivy’s sales reached only 94 million Swiss francs ($ 103 million) in the first half of the year.

In addition to POLARIX, Roche is also adding Polivy to a combo of its Rituxan, gemcitabine and Eloxatin from Sanofi in relapsed or refractory DLBCL in the POLARGO phase 3 trial. He is also trying to couple ADC with Venclexta, partner of AbbVie or with its bispecific antibodies CD20xCD3 mosunetuzumab and glofitamab in the disease.

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